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Sr Manager, Process Engineering
The successful candidate will manage a team responsible for the design of manufacturing equipment and supporting processes, and functional testing. This individual is responsible for ensuring that the equipment and supporting processes are ready for clinical or commercial production. The candidate must possess excellent communication and teamwork skills.
RESPONSIBILITIES (INCLUDE BUT NOT LIMITED TO):
* Support capital projects from the design perspective.
* Lead and support technology transfer within the company and to partners.
* Travel is required at a minimum of 25% of the time.
* Justifies the need for resources and ensures that all Process Engineering activities are prioritized in accordance with Pacira s strategical and tactical plan.
* Lead and direct all equipment related investigations and troubleshooting of Manufacturing Equipment to identify root causes. Implement solutions.
* Participate in cross functional teams dedicated to process improvement, efficiency, and optimization.
* Provide technical assessments for investigations, validation, and change controls.
* Ensure all mandatory training requirements are met for the team.
* Support GMP audits from regulatory agencies as well as internal audits.
* Minimum 8 years of Management Experience
* Minimum 15 years of relevant cGMP and technical experience
* BS degree in Engineering
* Must have management experience.
* Must possess excellent oral and written communication skills.
* Must be results oriented
* Experience with pilot-scale pharmaceutical/ biopharmaceutical process equipment
* Ability to work effectively, both independently and as an integral contributor toward achievement of project and company goals.
* Ability to manage multiple responsibilities with a high degree of self-motivation.
* Excellent and consistent organizational skills.
* Ability to work and comply with cGMP requirements
* Good observation skills and problem solving ability
* Team Player attitude: The willingness to work with peers towards company and department goals with dedication and willingness to do what is necessary to get the job done well and on time.